The centre is responsible for carrying out the
sponsor duties for the development of vaccine candidates
and for biomedical research initiated by researchers at
the Institut. For vaccine development, it is part of an
integrated organization including the Antiviral Immunity,
Biotherapy and Vaccines Unit (M.-L. Gougeon) and the
Cochin-Pasteur Clinical Research Centre (O.
Launay).

Vaccine
development

Grants have
been obtained allowing the centre to be involved in early
clinical development (proof of concept) of various
anti-infective vaccine candidates such as vaccines
against HIV, anthrax, malaria and shigellosis. In
addition, we prepared the early development plan of the
Mag-tn3 (C. Leclerc), an anti-cancer immunotherapy for
which the first clinical trial will be performed with
Institut Curie.

Vaccine against
Shigellosis

The estimated annual number of episodes of
Shigella infection is 165 million, the majority
being observed in developing countries and 70% of cases
being children. The annual number of deaths is roughly 1
million, two third being children below 5 years of
age.

SC599
Shigella vaccine phase I results

The SC599 is a live attenuated Shigella
dysenteriae type-1 (SD1) icsAentfepstxA:HgR oral vaccine developed by P.
Sansonetti. This vaccine was first evaluated in 28
healthy adult volunteers at the Saint-George Vaccine
Institute (SGVI) in London (D. Lewis). It was an
inpatient, prospective, open labeled not placebo
controlled study with sequential dose-escalating cohorts.
All doses tested from 102 up to
108 Colony Forming Unit (CFU) included were well
tolerated. An immune response was observed at doses
of 105 CFU and higher. The immunogenicity was defined as
the number of B lymphocytes producing IgM, IgG and IgA
specific for SD1 lipopolysaccharides as measured by the
Elispot technique (Paper under submission).

SC599
Shigella vaccine phase IIa (ongoing)

The phase I results provided the rationale for a
comparative double-blind placebo-controlled study of two
doses (105 and 107 CFU) of SC599 in
healthy volunteers. The primary objective is to
demonstrate the superiority in terms of immunogenicity of
the two tested doses versus placebo. The secondary
objective is to compare the clinical and biological
tolerance and to explore the vaccine shedding. One
hundred and eleven volunteers were enrolled (may-2005,
sept-2006) in the study at the SGVI and at the
Cochin-Pasteur CRC (Data analysis in 2007).

Biomedical
research support

The centre was/is involved
in various biomedical researches such as: Plasmodium
falciparum transcriptome analysis during parasite in
vitro development in erythrocytes from adult sickle-cell
trait carriers (P. David) ; mechanisms of tumour immunity
in patients with carcinoma of the bladder (M. Albert) ;
inter-relationships of hepatitis viruses genotypes and/or
variants with the environment and impact on liver cancer
(P. Pineau) ; development of a high-performance technique
for intravitam diagnosis of rabies in man (H.
Bourhy) ; human immune response to Yersinia pestis
(C. Demeure).

Teaching
activities

Members of the centre
are involved within two courses of the Pasteur School of
Infectiology: “Clinical trials for infectious and
tropical diseases” and “Epidemiology and
Biostatistics”.